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Drug Development and Approval
Drug Development and Approval
The FDA reviews and evaluates new drugs based on the evidence
presented from the clinical research studies performed by the drug
sponsor-typically a pharmaceutical company
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Summary of Drug Development and
Evaluation
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Preclinical Studies
Outlines the proposal to use the new drug for human testing in
clinical trials
Emphasis is on effectiveness
The review team evaluates the research on the safety of the drug and
its effectiveness
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm